Combined treatment for cataract and glaucoma treatment

ABSTRACT

A method is provided for treatment of cataract in combination with a glaucoma procedure while maintaining the intraocular pressure by permitting aqueous to flow out of an anterior chamber of the eye through a surgically stented pathway. A trabecular stent is adapted for implantation within the trabecular meshwork of an eye such that intraocular liquid flows controllably from the anterior chamber of the eye to Schlemm&#39;s canal, bypassing the trabecular meshwork. Depending upon the specific treatment contemplated, pharmaceuticals may be utilized in conjunction with the trabecular stent enabling post-cataract healing processes.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/537,782, filed Nov. 10, 2014, entitled “Combined Treatment forCataract and Glaucoma Treatment,” which is a continuation of U.S. patentapplication Ser. No. 13/118,338, filed May 27, 2011, now U.S. Pat. No.8,882,781 B2, issued Nov. 11, 2014, entitled “Combined Treatment forCataract and Glaucoma Treatment,” which is a continuation of U.S. patentapplication Ser. No. 11/653,815, filed Jan. 16, 2007, now U.S. Pat. No.7,951,155 B2, issued May 31, 2011, entitled “Combined Treatment forCataract and Glaucoma Treatment,” which is a continuation of U.S. patentapplication Ser. No. 10/165,616, filed Jun. 7, 2002, now U.S. Pat. No.7,163,543 B2, issued Jan. 16, 2007, entitled “Combined Treatment forCataract and Glaucoma Treatment,” which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/364,988, filed Mar. 15, 2002,entitled “Methods for Treating Combined Glaucoma and Cataract,” theentire contents of each one of which are hereby incorporated byreference herein.

BACKGROUND OF THE INVENTION Field of the Invention

The invention relates generally to surgical procedures for treatingcataract. More particularly, it relates to a treatment of cataract incombination with an ab interno procedure for maintaining the intraocularpressure by permitting intraocular liquid to flow out of an anteriorchamber of the eye through a surgically stented pathway.

Description of the Related Art

As is well known in the art, a human eye is a specialized sensory organcapable of light reception and is able to receive visual images. Aqueoushumor is a transparent liquid that fills the region between the cornea,at the front of the eye, and the lens. A trabecular meshwork, located inan anterior chamber angle formed between the iris and the cornea, servesas a drainage channel for intraocular liquid from the anterior chamber,which maintains a balanced pressure within the anterior chamber of theeye.

Artificial intraocular lenses are widely used to replace the humancrystalline lens of the eye. The human crystalline lens is a livingtransparent structure composed primarily of protein having a thicknessof about five millimeters and a diameter of about nine millimeters. Thelens is suspended behind the iris by zonula fibers that connect the lensto the ciliary body. A lens capsule surrounds the lens; the frontportion of the capsule is generally referred to as the anterior capsuleand the back portion is generally referred to as the posterior capsule.

The term “cataract” refers to the opacity of the lens of the eye. Thereare a variety of types of cataracts and for most cataracts, surgicalintervention is required to remove and replace the lens with anartificial intraocular lens.

There are a number of procedures and devices that have been developedfor the removal of the natural lens followed by the insertion of anartificial lens. The extraction procedure can generally be categorizedas intracapsular (i.e., where the lens is removed together with the lenscapsule) or extracapsular (such as where a portion of the anteriorcapsule is circularly removed (capsulorhexis) and the posterior capsuleis left intact).

Presently, phacoemulsification is a widely used method for the removalof diseased or damaged natural lens tissue. The phacoemulsificationprocess generally employs a small incision typically of about 2millimeters (mm) to about 4 mm in length through the cornea and a probeis used to ultrasonically break apart and remove the crystalline lensthrough the capsulorhexis.

SUMMARY OF THE INVENTION

During the cataract surgical procedure and immediately after theprocedure, it is important to maintain the intraocular pressure at adesired level. This is particularly important to a subset of cataractpatients that also has glaucoma. Therefore, there remains a clinicalneed for maintaining the intraocular pressure for cataract surgicaltreatment by allowing drainage of intraocular liquid or fluid through ahollow stented pathway bypassing the trabecular meshwork. The term“intraocular liquid (or fluid)” is herein intended to mean the aqueoushumor, the viscoelastic fluid, the normal physiological saline or thelike that stays in the eye at one time or the other.

Historically, about two percent of people in the United States haveglaucoma. Glaucoma is a separate disease from cataract; however, somepatients have both glaucoma and cataract so that is reasonable to treatboth in a combined procedure. Glaucoma is a group of eye diseasesencompassing a broad spectrum of clinical presentations, etiologies, andtreatment modalities. Glaucoma causes pathological changes in the opticnerve, visible on the optic disk, and it causes corresponding visualfield loss, resulting in blindness if untreated. Lowering intraocularpressure is the major treatment goal in all glaucomas.

In glaucomas associated with an elevation in eye pressure (intraocularhypertension), the source of resistance to outflow is mainly in thetrabecular meshwork. The tissue of the trabecular meshwork allows theaqueous humor (herein also referred to as “aqueous” and is one componentof the “intraocular liquid (or fluid)” referred to herein) to enterSchlemm's canal, which then empties into aqueous collector channels inthe posterior wall of Schlemm's canal and then into aqueous veins, whichform the episcleral venous system.

Aqueous is continuously secreted by a ciliary body around the lens, sothere is a constant flow of aqueous from the ciliary body to theanterior chamber of the eye. Pressure within the eye is determined by abalance between the production of aqueous and its exit through thetrabecular meshwork (major route) and uveal scleral outflow (minorroute). The portion of the trabecular meshwork adjacent to Schlemm'scanal (the juxtacanalicular meshwork) causes most of the resistance toaqueous outflow.

Because the trabecular meshwork and juxtacanalicular tissue togetherprovide the majority of resistance to the outflow of aqueous, they arelogical targets for surgical channeling with a stented pathway duringand after cataract surgery for maintaining balanced intraocularpressure. Various embodiments of glaucoma shunts are disclosed hereinfor aqueous to exit through the trabecular meshwork (major route) oruveal scleral outflow (minor route) or other route effective to reduceintraocular pressure (IOP). In some glaucoma patients, this surgicalchanneling may become the only viable alternative for lowering theintraocular pressure because of the patient's intolerance to glaucomamedicine immediately after cataract surgery.

What is desirable, therefore, is a combined procedure of ab internotrabecular stenting followed by a cataract treatment. The stentingadvantageously provides for aqueous drainage to maintain substantiallybalanced intraocular pressure during and after the procedure. Moreover,and advantageously, the combined procedure is fast, safe, and lessexpensive than currently available two-procedure modalities.

Advantageously, the accompanying glaucoma (or lowering IOP) procedureprovides the eye with a balanced intraocular pressure post-operativelywithout the need of an IOP-lowering drug that may complicate thesurgical success of the intended cataract procedure. Another advantageis that, a single incision in the cornea or sclera may be used toperform both surgical procedures. Moreover, and desirably, the glaucoma(or elevated IOP) and cataract may be treated in a single visitoperation that may be performed as an outpatient procedure with rapidvisual recovery and greatly decreased morbidity.

In accordance with one embodiment, a method is provided for treatingcataract of an eye while maintaining normal physiological intraocularpressure. The method comprising combination steps of establishing anopening through trabecular meshwork (also referred herein as “trabecularopening”) for maintaining normal physiological intraocular pressure,removing the cataract, and inserting an intraocular lens.

One aspect of the invention provides a trabecular stent having a lumentherein for inserting within the opening through trabecular meshwork.The step of establishing the opening through trabecular meshwork is byan ab interno procedure, wherein the ab interno procedure comprisesdelivering the trabecular stent through an incision on a cornea of theeye remote from the trabecular opening. The incision may beself-sealing.

The trabecular stent is adapted for implantation within a trabecularmeshwork of an eye such that intraocular liquid flows controllably froman anterior chamber of the eye to Schlemm's canal. The trabecular stentmay comprise a quantity of pharmaceuticals effective in treatingglaucoma and/or cataract, which are controllably released from thedevice into cells of the trabecular meshwork and/or Schlemm's canal.Depending upon the specific treatment contemplated, pharmaceuticals maybe utilized in conjunction with the trabecular stent such that liquid oraqueous flow either increases or decreases as desired. Placement of thetrabecular stent within the eye and incorporation, and eventual release,of a proven pharmaceutical glaucoma therapy will reduce, inhibit or slowthe effects of glaucoma and/or heal the injury from cataract procedure.

Another aspect of the invention provides a method of treating glaucomaor eye diseases around trabecular meshwork. The method comprisesproviding at least one pharmaceutical substance incorporated into atrabecular stent, implanting the trabecular stent within a trabecularmeshwork of an eye such that a first end of the trabecular stent ispositioned in an anterior chamber of the eye while a second end ispositioned in a Schlemm's canal, and allowing the stent to release aquantity of the pharmaceutical substance into the eye or eye tissue. Thefirst and second ends of the trabecular stent establish a fluidcommunication between the anterior chamber and Schlemm's canal to assistmaintaining a normal physiological intraocular pressure during or afterthe cataract procedure. The normal physiological intraocular pressure ismaintained between about 10 mmHg and 21 mmHg.

In another aspect of the invention, a method of regulating aqueous humoroutflow within an eye is provided. The method comprises creating anincision in a trabecular meshwork of the eye, wherein the incision issubstantially parallel with a circumference of a limbus of the eye,inserting an outlet section of a trabecular stent through the incisioninto Schlemm's canal such that the outlet section resides withinSchlemm's canal while an inlet section of the trabecular stent residesin the anterior chamber, initiating an outflow of aqueous humor from theanterior chamber through the trabecular stent into Schlemm's canal, andcontinuously maintaining the outflow of aqueous humor during and afterthe cataract procedure so as to maintain a normal physiologicalintraocular pressure during or after the cataract procedure.

Still another aspect of the invention provides a method of regulatingintraocular pressure within an eye. The method comprises making anincision passing into a trabecular meshwork of the eye, wherein theincision is oriented lengthwise substantially parallel with acircumference of a limbus. The incision establishes a fluidcommunication between an anterior chamber and Schlemm's canal of theeye. The method further comprises implanting a hollow trabecular stentthrough the incision such that an outlet section of the trabecular stentresides within Schlemm's canal and an inlet section of the trabecularstent resides within the anterior chamber. The method still furthercomprises establishing a fluid transfer from the anterior chamberthrough the trabecular stent into Schlemm's canal.

Another aspect of the invention provides a method of implanting atrabecular stent within an eye. The method known as an ab internoprocedure herein comprises creating a first incision in a cornea on afirst side of the eye, wherein the first incision passes through thecornea into an anterior chamber of the eye. The method further comprisespassing (across or U-turnedly) an incising device through the firstincision and moving a distal end of the incising device passing theanterior chamber to a trabecular meshwork residing on a second side ofthe eye, and using the incising device to create a second incision. Thesecond incision is in the trabecular meshwork, passing from the anteriorchamber through the trabecular meshwork into Schlemm's canal. In onealternate embodiment, the first incision in the cornea may be a veryshort distance from the second incision in the trabecular meshwork. Themethod further comprises inserting the trabecular stent into a distalspace of a delivery applicator. The delivery applicator comprises acannula portion having a distal end and a proximal end attached to asyringe portion. The cannula portion has at least one lumen and at leastone irrigating hole disposed between proximal and distal ends of thecannula portion. The irrigating hole is in fluid communication with thelumen. The distal space comprises a holder that holds the trabecularstent device during delivery and releases the trabecular stent when apractitioner activates deployment mechanism of the stent device. Themethod further comprises advancing the cannula portion and thetrabecular stent through the first incision, across or U-turnedlypassing the anterior chamber and into the second incision, wherein anoutlet section of the trabecular stent is implanted into Schlemm's canalwhile an inlet section of the trabecular stent remains in fluidcommunication with the anterior chamber. The method still furthercomprises releasing the trabecular stent from the holder of the deliveryapplicator.

In accordance with some embodiments, a method is provided for treatmentof cataract in combination with a glaucoma procedure while maintainingthe intraocular pressure by permitting aqueous to flow out of ananterior chamber of the eye through a surgically stented pathway. Atrabecular stent is adapted for implantation within the trabecularmeshwork of an eye such that intraocular liquid flows controllably fromthe anterior chamber of the eye to Schlemm's canal, bypassing thetrabecular meshwork. Depending upon the specific treatment contemplated,pharmaceuticals may be utilized in conjunction with the trabecular stentenabling post-cataract healing processes.

The trabecular shunt may include a pressure sensor 40 for measuring thepressure of the anterior chamber of an eye of a patient. The pressuresensor 40 may further include an electromagnetic (e.g., radiofrequency)transmitter 41 for wirelessly transmitting pressure measurements to apressure receiver 42 outside the patient's body.

In accordance with one embodiment, a method is provided of performingsurgery to lower intraocular pressure of an eye. The method comprisesthe step of providing an opening into an anterior chamber of the eye. Afirst instrument is inserted into the anterior chamber through theopening. The first instrument is used to perform a surgical procedureother than for lowering intraocular pressure. The first instrument isremoved from the anterior chamber. A second instrument is inserted intothe anterior chamber through the opening. The second instrument is usedto perform a surgical procedure for lowering intraocular pressure. Thesecond instrument is removed from the anterior chamber.

In accordance with another embodiment, a method is provided ofperforming surgery to lower intraocular pressure of an eye. The methodcomprises the step of providing an opening into an anterior chamber ofthe eye. A first instrument is inserted into the anterior chamberthrough the opening. The first instrument is used to perform a surgicalprocedure other than for lowering intraocular pressure. The firstinstrument is removed from the anterior chamber. A second instrument isinserted into the anterior chamber through the opening. The secondinstrument is used to implant a seton in a trabecular meshwork of theeye such that the seton conducts fluid from the anterior chamber toSchlemm's canal of the eye to lower intraocular pressure. The secondinstrument is removed from the anterior chamber without removing theseton from the trabecular meshwork.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention have been described herein above. Ofcourse, it is to be understood that not necessarily all such advantagesmay be achieved in accordance with any particular embodiment of theinvention. Thus, the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught or suggested herein without necessarily achieving otheradvantages as may be taught or suggested herein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the inventionwill become readily apparent to those skilled in the art from thefollowing detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus summarized the general nature of the invention and some ofits features and advantages, certain preferred embodiments andmodifications thereof will become apparent to those skilled in the artfrom the detailed description herein having reference to the figuresthat follow, of which:

FIG. 1 is a coronal, cross-sectional view of an eye;

FIG. 2 is an enlarged cross-sectional view of an anterior chamber angleof the eye of FIG. 1;

FIG. 3 is an oblique elevation view of a trabecular stent device havingfeatures and advantages in accordance with one embodiment of theinvention;

FIG. 4 is an oblique elevation view of a trabecular stent device havingfeatures and advantages in accordance with another embodiment of theinvention;

FIG. 5 is a close-up, cut-away view of an inlet section of thetrabecular stent device of FIGS. 3 and 4, illustrating aflow-restricting member retained within a lumen of the trabecular stentdevice and having features and advantages in accordance with anotherembodiment of the invention;

FIG. 6 is an oblique elevation view illustrating the placement of oneend of the trabecular stent device of FIG. 3 through a trabecularmeshwork in accordance with one embodiment of the invention;

FIG. 7 is an oblique elevation view of a preferred implantation of thetrabecular stent device of FIG. 3 through a trabecular meshwork inaccordance with one embodiment of the invention;

FIG. 8 is an oblique elevation view illustrating the placement of oneend of the trabecular stent device of FIG. 3 through a trabecularmeshwork, wherein the trabecular stent device is passed over aguidewire, in accordance with one embodiment of the invention;

FIG. 9 is an enlarged, cross-sectional view of a preferred method ofimplanting the trabecular stent device of FIG. 3 within an eye andhaving features and advantages in accordance with one embodiment of theinvention;

FIG. 10 is a perspective view of an anterior chamber angle of an eye,illustrating the trabecular stent device of FIG. 3 positioned within atrabecular meshwork and having features and advantages in accordancewith one embodiment of the invention;

FIG. 11 is a simplified schematic view of a lens of an eye;

FIG. 12 is a top plan view of one embodiment of an anterior chamberintraocular lens;

FIG. 13 is a side view of the intraocular lens of FIG. 12;

FIG. 14 is a top plan view of one embodiment of a posterior chamberintraocular lens;

FIG. 15 is a side view of the intraocular lens of FIG. 14;

FIG. 16 is a simplified graphical representation of the intraocularpressure (IOP) during and after cataract surgery and illustrating thebenefits of a preferred pressure control scheme in accordance with oneembodiment of the invention;

FIG. 17 is a simplified schematic view of a capsule of an eye after anextracapsular cataract extraction procedure; and

FIG. 18 is a simplified schematic block diagram illustrating steps of acombined procedure for cataract and glaucoma treatment having featuresand advantages in accordance with one embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The preferred embodiments of the invention described herein relateparticularly to a surgical treatment of cataract in combination with asurgical and therapeutic treatment of glaucoma through maintainingnormal intraocular pressure. While the description sets forth variousembodiment specific details, it will be appreciated that the descriptionis illustrative only and should not be construed in any way as limitingthe invention. Furthermore, various applications of the invention, andmodifications thereto, which may occur to those who are skilled in theart, are also encompassed by the general concepts described herein andbelow.

FIG. 1 is a cross-sectional view of an eye 10, while FIG. 2 is aclose-up view showing the relative anatomical locations of a trabecularmeshwork 21, an anterior chamber 20, and a Schlemm's canal 22. A sclera11 is a thick collagenous tissue which covers the entire eye 10 except aportion which is covered by a cornea 12. The cornea 12 is a thintransparent tissue that focuses and transmits light into the eye andthrough a pupil 14, which is a circular hole in the center of an iris 13(colored portion of the eye). The cornea 12 merges into the sclera 11 ata juncture referred to as a limbus 15. A ciliary body 16 extends alongthe interior of the sclera 11 and is coextensive with a choroid 17. Thechoroid 17 is a vascular layer of the eye 10, located between the sclera11 and a retina 18. An optic nerve 19 transmits visual information tothe brain and is the anatomic structure that is progressively destroyedby glaucoma.

The anterior chamber 20 of the eye 10 (FIGS. 1 and 2), which is boundanteriorly by the cornea 12 and posteriorly by the iris 13 and a lens26, is filled with aqueous humor (also herein referred to as “aqueous”).Aqueous is produced primarily by the ciliary body 16, then movesanteriorly through the pupil 14 and reaches an anterior chamber angle25, formed between the iris 13 and the cornea 12.

Referring in particular to FIGS. 1 and 2, in a normal eye, aqueous isremoved from the anterior chamber 20 through the trabecular meshwork 21.Aqueous passes through the trabecular meshwork 21 into Schlemm's canal22 and thereafter through a plurality of aqueous veins 23, which mergewith blood-carrying veins, and into systemic venous circulation.Intraocular pressure (IOP) is maintained by an intricate balance betweensecretion and outflow of aqueous in the manner described above. Glaucomais, in most cases, characterized by an excessive buildup of aqueous inthe anterior chamber 20 which leads to an increase in intraocularpressure. Fluids are relatively incompressible, and thus intraocularpressure is distributed relatively uniformly throughout the eye 10.

As shown in FIG. 2, the trabecular meshwork 21 is adjacent a smallportion of the sclera 11. Exterior to the sclera 11 is a conjunctiva 24.Traditional procedures that create a hole or opening for implanting adevice through the tissues of the conjunctiva 24 and sclera 11 involveextensive surgery, as compared to surgery for implanting a device, asdescribed herein, which ultimately resides entirely within the confinesof the sclera 11 and cornea 12. As discussed in greater detail below, inaccordance with some embodiments, a trabecular stenting device isutilized for establishing an outflow pathway, passing through thetrabecular meshwork 21.

Trabecular Stenting Device for Reducing Intraocular Pressure (IOP)

FIG. 3 illustrates one preferred embodiment of a trabecular stentingdevice 31 which facilitates the outflow of aqueous from the anteriorchamber 20 into Schlemm's canal 22, and subsequently into the aqueouscollectors and the aqueous veins so that intraocular pressure (IOP) isreduced. In the illustrated embodiment, the trabecular stenting device31 comprises an inlet section 2, having a lumen 3″ with an inlet opening3, a middle section 4, and an outlet section 9.

Referring to FIG. 3, the middle section 4 may be an extension of, or maybe coextensive with, the inlet section 2. The outlet section 9 ispreferably somewhat flexible to facilitate positioning of the outletsection 9 within an outflow pathway of the eye 10. The outlet section 9is preferably substantially perpendicular to the middle section 4.“Substantially perpendicular,” as used herein, is generally defined assubtending an angle between longitudinal axes of the sections 4, 9ranging between about 30° (degrees) and about 150° (degrees). The device31 further comprises at least one lumen 7 within sections 4 and 9 whichis in fluid communication with the inlet opening 3 (and/or lumen 3″) ofsection 2, thereby facilitating transfer of aqueous through the device31.

The trabecular stenting device 31 (FIG. 3) of the preferred embodimentsmay be made of a biocompatible titanium material or titanium-containingalloy, such as Nitinol. In accordance with one aspect, the trabecularstent is coated with a compound having properties of anticoagulant,antiplatelet, antifibrin and antithrombus that is selected from a groupconsisting of heparin, warfarin, hirudin, heparinoid, argatroban,forskolin, vapiprost, prostacyclin, dextran, dipyridamole, thrombininhibitor, and combinations thereof.

As shown in FIG. 3, the outlet section 9 preferably has a first outletend 6 and a second, opposite outlet end 5. The lumen 7 within the outletsection 9 opens to at least one of the outlet ends 5,6. Furthermore, theoutlet section 9 may have a plurality of side openings 77, each of whichis in fluid communication with the lumen 7, for transmission of aqueous.The middle section 4 is connected to or coextensive with the outletsection 9 and is disposed between the first outlet end 6 and the secondoutlet end 5.

In one preferred embodiment, the outlet section 9 (FIG. 3) is curvedaround a point, or curve center, and the middle section 4 extendssubstantially along a plane that contains the curve center. In thisembodiment, the outlet section 9 has a radius of curvature rangingbetween about 4 millimeters (mm) and about 10 mm.

Referring in particular to FIG. 3, as will be apparent to a personskilled in the art, the lumen 7 and the remaining body of the outletsection 9 may have a cross-sectional shape that is oval, circular, orother appropriate shape. The cross-sectional shapes of the lumen 7 andthe outlet section 9 preferably conform to the shape of the outflowpathway into which the outlet section 9 is placed. The opening of thelumen 7 of the outlet ends 5,6 may be ovoid in shape to match thecontour of Schlemm's canal 22. Further, an outer contour of the outletsection 9 may be elliptical (e.g., ovoid) in shape to match the contourof Schlemm's canal 22. This serves to minimize rotational movement ofthe outlet section 9 within Schlemm's canal 22, and thereby stabilizesthe inlet section 2 with respect to the iris and cornea.

In the illustrated embodiment of FIG. 3, a circumferential ridge 8 isprovided at the junction of the inlet section 2 and the middle section 4to facilitate stabilization of the device 31 once implanted within theeye 10. Preferably, the middle section 4 has a length (between the ridge8 and the outlet section 9) that is roughly equal to a thickness of thetrabecular meshwork 21, which typically ranges between about 100 micronsor micrometers (μm) and about 300 μm. In addition, the outlet section 9may advantageously be formed with a protuberance or spur projectingtherefrom so as to further stabilize the device 31 within the eye 10without undue suturing.

FIG. 4 illustrates a modified embodiment of a trabecular stent 31A whichfacilitates the outflow of aqueous from the anterior chamber 20 intoSchlemm's canal 22, and subsequently into the aqueous collectors and theaqueous veins so that intraocular pressure is reduced. The device 31Acomprises an inlet section 2A, a middle section 4A, and an outletsection 9A. The device 31A further comprises at least one lumen 3Atraversing the sections 2A, 4A, 9A and providing fluid communicationtherebetween. The lumen 3A facilitates the transfer of aqueous from theinlet section 2A through the device 31A.

Referring in particular to FIG. 4, the outlet section 9A has opposedends 5A, 6A. The outlet section 9A is preferably curved, and may also besomewhat flexible, to facilitate positioning of the outlet section 9Awithin an existing outflow pathway of the eye 10. The outlet section 9Afurther comprises an elongate trough 7A for transmitting, or venting,aqueous. The elongate trough 7A is connected to and in fluidcommunication with the lumen 3A within the trabecular stenting device31A.

In the illustrated embodiment of FIG. 4, a circumferential ridge 8A isprovided at the junction of the inlet section 2A and the middle section4A to facilitate stabilization of the device 31A once implanted withinthe eye 10. Preferably, the middle section 4A has a length (between theridge 8A and the outlet section 9A) that is roughly equal to thethickness of the trabecular meshwork 21, which typically ranges betweenabout 100 μm and about 300 μm. In addition, the outlet section 9A mayadvantageously be formed with a protuberance or barb projectingtherefrom so as to further stabilize the device 31A within the eye 10without undue suturing.

As will be appreciated by those of ordinary skill in the art, thedevices 31 (FIG. 3) and 31A (FIG. 4) may advantageously be practicedwith a variety of sizes and shapes without departing from the scope ofthe invention. Depending upon the distance between the anterior chamber20 and the drainage vessel (e.g., a vein) contemplated, the devices 31,31A may have a length ranging from about 0.05 centimeters (cm) to over10 centimeters (cm). Preferably, the devices 31 and 31A have an outsidediameter ranging between about 30 μm and about 500 μm, with the lumens7, 3A having diameters ranging between about 20 μm and about 250 μm,respectively. In addition, the devices 31, 31A may have a plurality oflumens to facilitate transmission of multiple flows of aqueous.

Still referring in particular to FIGS. 3 and 4, the inlet sections 2, 2Ahave longitudinal axes that form an angle θ ranging between about 20°(degrees) and about 150° (degrees) relative to the longitudinal axes ofthe middle sections 4, 4A, respectively. More preferably, the angles θbetween the longitudinal axes of the inlet sections 2, 2A and the middlesections 4, 4A range between about 30° (degrees) and about 60°(degrees), respectively.

FIG. 5 is a close-up view of the inlet section 2 and/or 2A of thetrabecular stenting device 31 and/or 31A, illustrating aflow-restricting member 72 which is tightly retained within a lumen 78(or 3″). In the illustrated embodiment, the flow-restricting member 72is shown located close to an inlet side 71 of the inlet section 2 and/or2A. The flow-restricting member 72 serves to selectively restrict atleast one component in blood from moving retrograde, i.e., from theoutlet section 9 (FIG. 3) and/or 9A (FIG. 4) into the anterior chamber20 of the eye 10.

In modified embodiments, the flow-restricting member 72 (FIG. 5) may besituated in any location within the device 31 and/or 31A such that bloodflow is restricted from retrograde motion. More than oneflow-restricting member 72 mat also be efficaciously used, as needed ordesired. The flow-restricting member 72 may, in some embodiments, be afilter made of a material selected from the following filter materials:expanded polytetrafluoroethylene, cellulose, ceramic, glass, Nylon,plastic, and fluorinated material such as polyvinylidene fluoride(“PVDF”) (trade name: Kynar, by DuPont), and combinations thereof.

The trabecular stenting devices 31 (FIG. 3) and/or 31A (FIG. 4) may bemade by molding, thermo-forming, or other micro-machining techniques,among other techniques. The trabecular stenting devices 31, 31Apreferably comprise a biocompatible material such that inflammationarising due to irritation between the outer surface of the device 31,31A and the surrounding tissue is minimized.

Biocompatible materials which may be used for the devices 31 (FIG. 3)and/or 31A (FIG. 4) preferably include, but are not limited to,titanium, medical grade silicone, e.g., Silastic™, available from DowComing Corporation of Midland, Mich.; and polyurethane, e.g.,Pellethane™, also available from Dow Corning Corporation.

In other embodiments, the devices 31 (FIG. 3) and/or 31A (FIG. 4) maycomprise other types of biocompatible material, such as, by way ofexample, polymethylmethacrylate (PMMA), polyvinyl alcohol, polyvinylpyrrolidone, collagen, heparinized collagen, polytetrafluoroethylene,expanded polytetrafluoroethylene, fluorinated polymer, fluorinatedelastomer, flexible fused silica, polyolefin, polyester, polysilicon,and/or a mixture of the aforementioned biocompatible materials, and thelike. In still other embodiments, composite biocompatible material maybe used, wherein a surface material may be used in addition to one ormore of the aforementioned materials. For example, such a surfacematerial may include polytetrafluoroethylene (PTFE) (such as Teflon™),polyimide, hydrogel, heparin, therapeutic drugs (such as beta-adrenergicantagonists and other anti-glaucoma drugs, or antibiotics), and thelike.

The polymer in accordance with the preferred embodiments should bebiocompatible, for example a polymeric material which, in the amountsemployed, is non-toxic and chemically inert as well as substantiallynon-immunogenic and non-inflammatory. Suitable polymeric materials caninclude, but are not limited to, polycaprolactone (PCL), poly-D,L-lacticacid (DL-PLA), poly-L-lactic acid (L-PLA), poly(lactide-co-glycolide),poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone,polyorthoester, polyanhydride, poly(glycolic acid), poly(glycolicacid-cotrimethylene carbonate), polyphosphoester, polyphosphoesterurethane, poly (amino acids), cyanoacrylates, poly(trimethylenecarbonate), poly(iminocarbonate), copoly(ether-esters), polyalkyleneoxalates, polyphosphazenes, polyiminocarbonates, and aliphaticpolycarbonates, fibrin, fibrinogen, cellulose, starch, collagen,polyurethane, polyethylene, polyethylene terephthalate, ethylene vinylacetate, ethylene vinyl alcohol, silicone, polyethylene oxide,polybutylene terephthalate (PBT)-co-PEG, PCL-co-PEG, PLA-co-PEG,polyacrylates, polyoxaesters, polyvinyl pyrrolidone (PVP),polyacrylamide (PAAm), and combinations thereof.

As is well known in the art, a device coated or loaded with aslow-release substance can have prolonged effects on local tissuesurrounding the device. The slow-release delivery can be designed suchthat an effective amount of substance is released over a desiredduration. “Substance,” as used herein, is generally defined as anytherapeutic or active drug that can stop, mitigate, slow-down or reverseundesired disease processes.

In one embodiment, the stent devices 31 (FIG. 3) and/or 31A (FIG. 4) maybe made of a biodegradable (also including bioerodible) material admixedwith a substance for substance slow-release into ocular tissues. Inanother embodiment, polymer films may function as substance containingrelease devices whereby the polymer films may be coupled or secured tothe devices 31 and/or 31A. The polymer films may be designed to permitthe controlled release of the substance at a chosen rate and for aselected duration, which may also be episodic or periodic. Such polymerfilms may be synthesized such that the substance is bound to the surfaceor resides within a pore in the film so that the substance is relativelyprotected from enzymatic attack. The polymer films may also be modifiedto alter their hydrophilicity, hydrophobicity and vulnerability toplatelet adhesion and enzymatic attack.

Furthermore, the film may be coupled (locally or remotely) to a powersource such that when substance delivery is desired, a brief pulse ofcurrent is provided to alter the potential on the film to cause therelease of a particular amount of the substance for a chosen duration.Application of current causes release of a substance from the surface ofthe film or from an interior location in the film such as within a pore.The rate of substance delivery is altered depending on the degree ofsubstance loading on the film, the voltage applied to the film, and bymodifying the chemical synthesis of substance delivery polymer film.

The power-activated substance delivery polymer film may be designed tobe activated by an electromagnetic field, such as, by way of example,Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI), orshort range Radio Frequency (RF) transmission (such as Bluetooth). Inaddition, ultrasound can be used to cause a release of a particularamount of substance for a chosen duration. This is particularlyapplicable to a substance coated device or a device made of a substratecontaining the desired substance.

Exemplary Drug Therapies

The stent devices 31 (FIG. 3) and/or 31A (FIG. 4) may be used for adirect release of pharmaceutical preparations into ocular tissues. Asdiscussed above, the pharmaceuticals may be compounded within thedevices 31 and/or 31A or form a coating on the devices 31 and/or 31A.Any known drug therapy for glaucoma may be utilized, including but notlimited to, the following.

U.S. Pat. No. 6,274,138 B1, issued Aug. 14, 2001, to Bandman et al. andU.S. Pat. No. 6,231,853 B1, issued May 15, 2001, to Hillman et al., theentire contents of each one of which are hereby incorporated byreference herein, disclose the function of mitochondria and toxicsubstances synthesized as a metabolic byproduct within mitochondria ofcells. Perry and associates (Perry H D et al. “Topical cyclosporin A inthe management of postkeratoplasty glaucoma” Cornea 16:284-288, 1997,hereby incorporated by reference herein) report that topicalcyclosporin-A has been shown to reduce post-surgical increases inintraocular pressure. It is proposed that such compounds with knowneffects on mitochondrial stability might be effective in treatingtrabecular meshwork. An antagonistic drug to neutralize the toxicbyproduct or a stabilizing drug to effect mitochondrial stability isbelieved able to restore the mitochondria function and subsequentlymitigate the dysfunction of the trabecular meshwork.

Many types of open angle glaucoma exist; therefore, a number ofpotential therapeutic mitochondrial interventions may be possible. It isone aspect of the invention to provide a method for stimulatingmitochondrial survival/function to prevent demise and secondaryapoptosis (that is, programmed cell death). In primary open angleglaucoma, the intraocular pressure increases in response to a decreasein the outflow of aqueous. Research has shown that the number ofjuxtacanalicular endothelial cells in Schlemm's canal is lower inindividuals with glaucoma compared to normals (Grierson I et al.,“Age-related changes in the canal of Schlemm” Exp Eye Res, 1984;39(4):505-512, hereby incorporated by reference herein). Since thesecells are involved in the energy-dependent egress of aqueous, theirdemise results in elevated intraocular pressure. Therefore, themitochondrial treatment objectives for glaucoma preferably include notonly the prevention of further endothelial cell death, but also therestoration or boosting of mitochondrial function in the remainingcells. The cells may be made more resilient to elevated intraocularpressure with mitochondrial stimulating therapy by drug slow release. Amonoamine oxidase inhibitor, deprenyl, that has been used in thetreatment of Parkinson's disease may play a role in reducing neuronalapoptosis in glaucoma; Tatton in U.S. Pat. No. 5,981,598, issued Nov. 9,1999, the entire contents of which are hereby incorporated by referenceherein, states that the primary metabolite of deprenyl,desmethyldeprenyl (DES) is involved in the maintenance of themitochondrial membrane and prevents apoptotic degradation. It is oneaspect of the invention to provide a method for prevention or slowing ofapoptotic degradation of optic nerve cells or other cells in trabecularmeshwork by administering an effective amount of compounds that energizethe mitochondria in the neurons aids the cells by enabling them tobetter remove compounds that lead to their apoptotic degradation.

U.S. Pat. No. 6,201,001 B1, issued Mar. 13, 2001, to Wang et al., theentire contents of which are hereby incorporated by reference herein,discloses Imidazole antiproliferative agents useful for neovascularglaucoma.

U.S. Pat. No. 6,228,873 B1, issued May 8, 2001, to Brandt et al., theentire contents of which are hereby incorporated by reference herein,discloses a new class of compounds that inhibit function of sodiumchloride transport in the thick ascending limb of the loop of Henle,wherein the preferred compounds that are useful are furosemide,piretanide, benzmetanide, bumetanide, torsemide and derivatives thereof.

U.S. Pat. No. 6,194,415 B1, issued Feb. 27, 2001, to Wheeler et al., theentire contents of which are hereby incorporated by reference herein,discloses a method of using quinoxalines (2-imidazolin-2-ylamino) intreating neural injuries (e.g. glaucomatous nerve damage).

U.S. Pat. No. 6,060,463, issued May 9, 2000, to Freeman and U.S. Pat.No. 5,869,468, issued Feb. 9, 1999, to Freeman, the entire contents ofeach one of which are hereby incorporated by reference herein, disclosetreatment of conditions of abnormally increased intraocular pressure byadministration of phosphonylmethoxyalkyl nucleotide analogs and relatednucleotide analogs.

U.S. Pat. No. 5,925,342, issued Jul. 20, 1999, to Adorante et al., theentire contents of which are hereby incorporated by reference herein,discloses a method for reducing intraocular pressure by administrationof potassium channel blockers.

U.S. Pat. No. 5,814,620, issued Sep. 29, 1998, to Robinson et al., theentire contents of which are hereby incorporated by reference herein,discloses a method of reducing neovascularization and of treatingvarious disorders associated with neovascularization. These methodsinclude administering to a tissue or subject a syntheticoligonucleotide.

U.S. Pat. No. 5,767,079, issued Jun. 16, 1998, to Glaser et al., theentire contents of which are hereby incorporated by reference herein,discloses a method for treatment of ophthalmic disorders by applying aneffective amount of Transforming Growth Factor-Beta (TGF-beta or TGF-β)to the affected region.

U.S. Pat. No. 5,663,205, issued Sep. 2, 1997, to Ogawa et al., theentire contents of which are hereby incorporated by reference herein,discloses a pharmaceutical composition for use in glaucoma treatmentwhich contains an active ingredient5-[1-hydroxy-2-[2-(2-methoxyphenoxyl)ethylamino]ethyl]-2-methylbenzenesulfonamide. This agent is free from side effects, and stable and has anexcellent intraocular pressure reducing activity at its lowconcentrations, thus being useful as a pharmaceutical composition foruse in glaucoma treatment.

U.S. Pat. No. 5,652,236, issued Jul. 29, 1997, to Krauss, the entirecontents of which are hereby incorporated by reference herein, disclosespharmaceutical compositions and a method for treating glaucoma and/orocular hypertension in the mammalian eye by administering thereto apharmaceutical composition which contains as the active ingredient oneor more compounds having guanylate cyclase inhibition activity. Examplesof guanylate cyclase inhibitors utilized in the pharmaceuticalcomposition and method of treatment are methylene blue, butylatedhydroxyanisole and N-methylhydroxylamine.

U.S. Pat. No. 5,547,993, issued Aug. 20, 1996, to Miki, the entirecontents of which are hereby incorporated by reference herein, disclosesthat 2-(4-methylaminobutoxy) diphenylmethane or a hydrate orpharmaceutically acceptable salt thereof have been found useful fortreating glaucoma.

U.S. Pat. No. 5,502,052, issued Mar. 26, 1996, to DeSantis, the entirecontents of which are hereby incorporated by reference herein, disclosesuse of a combination of apraclonidine and timolol to control intraocularpressure. The compositions contain a combination of an alpha-2 agonist(e.g., para-amino clonidine) and a beta blocker (e.g., betaxolol).

U.S. Pat. No. 6,184,250 B1, issued Feb. 6, 2001, to Klimko et al., theentire contents of which are hereby incorporated by reference herein,discloses use of cloprostenol and fluprostenol analogues to treatglaucoma and ocular hypertension. The method comprises topicallyadministering to an affected eye a composition comprising atherapeutically effective amount of a combination of a first compoundselected from the group consisting of beta-blockers, carbonic anhydraseinhibitors, adrenergic agonists, and cholinergic agonists; together witha second compound.

U.S. Pat. No. 6,159,458, issued Dec. 12, 2000, to Bowman et al., theentire contents of which are hereby incorporated by reference herein,discloses an ophthalmic composition that provides sustained release of awater soluble medicament formed by comprising a crosslinkedcarboxy-containing polymer, a medicament, a sugar and water.

U.S. Pat. No. 6,110,912, issued Aug. 29, 2000, to Kaufman et al., theentire contents of which are hereby incorporated by reference herein,discloses methods for the treatment of glaucoma by administering anophthalmic preparation comprising an effective amount of anon-corneotoxic serine-threonine kinase inhibitor, thereby enhancingaqueous outflow in the eye and treatment of the glaucoma. In someembodiments, the method of administration is topical, whereas it isintracameral in other embodiments. In still further embodiments, themethod of administration is intracanalicular.

U.S. Pat. No. 6,177,427 B1, issued Jan. 23, 2001, to Clark et al., theentire contents of which are hereby incorporated by reference herein,discloses compositions of non-steroidal glucocorticoid antagonists fortreating glaucoma or ocular hypertension.

U.S. Pat. No. 5,952,378, issued Sep. 14, 1999, to Stjernschantz et al.,the entire contents of which are hereby incorporated by referenceherein, discloses the use of prostaglandins for enhancing the deliveryof drugs through the uveoscleral route to the optic nerve head fortreatment of glaucoma or other diseases of the optic nerve as well assurrounding tissue. The method for enhancing the delivery to the opticnerve head comprises contacting a therapeutically effective amount of acomposition containing one or more prostaglandins and one or more drugsubstances with the eye at certain intervals.

Trabecular Device Use and Operation

One preferred method for increasing aqueous outflow in the eye 10 (FIGS.1 and 2) of a patient, to reduce intraocular pressure therein, comprisesbypassing the trabecular meshwork 21. Though much of the discussionbelow refers to the device 31 of FIG. 3, the skilled artisan willreadily appreciate that the device 31A of FIG. 4 may be efficaciouslyutilized in a substantially similar manner.

In operation, the middle section 4 of the device 31 (FIG. 3) isadvantageously placed across the trabecular meshwork 21 through a slitor opening. This opening can be created by using a laser, a knife, orother suitable surgical cutting instrument. The opening mayadvantageously be substantially horizontal, i.e., extendinglongitudinally in the same direction as the circumference of the limbus15 (FIG. 2). Other opening directions may also be efficaciously used, asneeded or desired. The opening may advantageously be oriented at anyangle, relative to the circumference of the limbus 15, that isappropriate for inserting the device 31 through the trabecular meshwork21 and into Schlemm's canal 22 or other outflow pathway, as will beapparent to those skilled in the art.

Referring in particular to FIG. 3, the middle section 4 may besemi-flexible and/or adjustable in position relative to the inletsection 2 and/or the outlet section 9, further adapting the device 31for simple and safe glaucoma implantation. Furthermore, the outletsection 9 may be positioned into fluid collection channels of thenatural outflow pathways. Such natural outflow pathways includeSchlemm's canal 22, aqueous collector channels, aqueous veins, andepiscleral veins. The outlet section 9 may be positioned into fluidcollection channels up to at least the level of the aqueous veins, withthe device inserted in a retrograde or antegrade fashion.

FIG. 6 generally illustrates one step in the implantation of thetrabecular stenting device 31 through the trabecular meshwork 21. Theoutlet section 9 of the device 31 is inserted into an opening 61 in thetrabecular meshwork 21. A practitioner or surgeon may create the opening61 “ab interno” from the interior surface 65 of the trabecular meshwork21. The practitioner then advances the first outlet end 6 of the outletsection 9 through the opening 61 into a first side of Schlemm's canal 22or other suitable outflow pathway within the eye 10. Next, thepractitioner advances the second outlet end 5 through the opening 61 andinto a second side of Schlemm's canal 22. The advancing of the secondoutlet end 5 may be facilitated by slightly pushing the second outletend 5 through the opening 61.

FIG. 7 generally illustrates a further stage in deployment of the device31, wherein the entire outlet section 9 of the device 31 is implantedwithin Schlemm's canal 22, beneath the trabecular meshwork 21. At thisstage, the lumen 3″ (or inlet opening 3) of the implanted device 31provides an enhanced fluid communication through the trabecular meshwork21 and between the anterior chamber 20 (FIGS. 1 and 2) and Schlemm'scanal 22.

FIG. 8 shows an additional and/or modified step in the implantation ofthe trabecular stenting device 31 through the trabecular meshwork 21.The practitioner inserts a distal end 63 of a guidewire 64 through theopening 61 into the first side Schlemm's canal 22. The practitioner thenadvances the first outlet end 6 of the outlet section 9 into Schlemm'scanal 22 by “riding,” or advancing, the trabecular stenting device 31 onthe guidewire 64. As will be apparent to those skilled in the art, theguidewire 64 will have a shape and size conforming to the shape and sizeof the lumen 7; and as such, may have an elliptical (e.g., oval) shape,a D-shape, a round shape, or an irregular (asymmetric) shape which isadapted for nonrotatory engagement with or for the device 31.

One method for increasing aqueous outflow within the eye 10 of apatient, and thus reduce intraocular pressure therein, comprises: (a)creating an opening in the trabecular meshwork 21, wherein thetrabecular meshwork 21 includes a deep side and a superficial side; (b)inserting the trabecular stenting device 31 into the opening; and (c)transmitting aqueous or intraocular liquid through the device 31, tobypass the trabecular meshwork 21, from the deep side to the superficialside of the trabecular meshwork 21. This “transmitting” of aqueous orintraocular liquid is preferably passive, i.e., aqueous or intraocularliquid flows out of the anterior chamber 20 due to a pressure gradientbetween the anterior chamber 20 and the aqueous venous system 23.

Another method for increasing aqueous outflow within the eye 10 of apatient, and thus reduce intraocular pressure therein, comprises a)providing at least one pharmaceutical substance incorporated into atrabecular stenting device at about the middle section of the device; b)implanting the trabecular stenting device within a trabecular meshworkof an eye such that the middle section is configured substantiallywithin the trabecular meshwork, the stenting device having a first endpositioned in an anterior chamber of the eye while a second end ispositioned inside a Schlemm's canal, wherein the first and the secondends of the trabecular stenting device establish a fluid communicationbetween the anterior chamber and the Schlemm's canal; and c) allowingthe middle section of the trabecular stenting device to release aquantity of said pharmaceutical substance into the trabecular meshwork.

It should be understood that the devices 31 (FIG. 3) and 31A (FIG. 4)are not limited to implantation within only Schlemm's canal 22, asgenerally depicted by the embodiments of FIGS. 6-8. Rather, the devices31 and 31A may advantageously be implanted within and/or used inconjunction with a variety of other natural outflow pathways, orbiological tubular structures, as mentioned above. As will be apparentto those of ordinary skill in the art, the devices 31 and 31A mayadvantageously be used in conjunction with substantially any biologicaltubular structure without detracting from or limiting the scope of theinvention.

FIG. 9 generally illustrates a preferred method by which the trabecularstenting device 31 is implanted within the eye 10. In the illustratedmethod, a delivery applicator 51 is provided, which preferably comprisesa syringe portion 54 and a cannula portion 55 which contains at leastone lumen (not shown). The cannula portion 55 preferably has a size ofabout 30 gauge. However, in other embodiments, the cannula portion 55may have a size ranging between about 16 gauge and about 40 gauge. Adistal section of the cannula portion 55 has at least one irrigatinghole 53 in fluid communication with the lumen.

Still referring in particular to FIG. 9, a holder for holding the device31 comprises a lumen 56 having a proximal end 57. In other embodiments,the holder may advantageously comprise a lumen, a sheath, a clamp,tongs, a space, and the like. The proximal end 57 of the lumen 56 ispreferably sealed off from the remaining lumen of the cannula portion 55and the irrigating hole 53 of the cannula portion 55. As will berecognized by those skilled in the art, however, in other embodiments ofthe cannula portion 55, the lumen 56 may advantageously be placed influid communication with the lumen and irrigating hole 53 of the cannulaportion 55 without detracting from or limiting the scope of theinvention.

In the method illustrated in FIG. 9, the device 31 is placed into thelumen 56 of the delivery applicator 51 and then advanced to a desiredimplantation site within the eye 10. The delivery applicator 51 holdsthe device 31 securely during delivery and releases it when thepractitioner initiates deployment of the device 31.

In one preferred embodiment of trabecular meshwork surgery, a patient isplaced in a supine position, prepped, draped, and appropriatelyanesthetized. A small incision 52 (FIG. 9) is then made through thecornea 12. In one embodiment, the incision 52 is made through the cornea12 near or proximate to the limbus 15 (FIG. 2). In another embodiment,the incision 52 is made substantially at the limbus 15.

The incision 52 (FIG. 9) preferably has a surface length less than about1.0 millimeters (mm) in length and may advantageously be self-sealing.Through the incision 52, the trabecular meshwork 21 is accessed, whereinan incision is made with an irrigating knife (not shown). The device 31is then advanced through the corneal incision 52 and across the anteriorchamber 20, while the device 31 is held in the delivery applicator 51,under gonioscopic, microscopic, or endoscopic guidance. After the device31 is appropriately implanted, the applicator 51 is withdrawn and thetrabecular meshwork surgery is concluded.

FIG. 10 generally illustrates the use of the trabecular stenting device31 for establishing an outflow pathway, passing from the anteriorchamber 20 through the trabecular meshwork 21 to Schlemm's canal 22. Asillustrated, an opening has been created in the trabecular meshwork 21.As will be appreciated by those of ordinary skill in the art, such anopening in the trabecular meshwork 21 may comprise an incision made witha microknife, a pointed guidewire, a sharpened applicator, ascrew-shaped applicator, an irrigating applicator, a barbed applicator,and the like. In modified embodiments, the trabecular meshwork 21 mayadvantageously be dissected with an instrument similar to a retinal pickor microcurette. Furthermore, the opening may advantageously be createdby fiber optic laser ablation.

Referring again to FIG. 10, the outlet section 9 of the device 31 hasbeen inserted in its entirety into the opening in the trabecularmeshwork 21. The inlet section 2 is exposed to the anterior chamber 20,while the outlet section 9 is positioned near an interior surface 43 ofSchlemm's canal 22. In other embodiments, the outlet section 9 mayadvantageously be placed into fluid communication with other naturaloutflow pathways, such as, but not limited to, aqueous collectorchannels, aqueous veins, and episcleral veins, as described above. Adevice such as the device 31A of FIG. 4, wherein the outflow section 9Ahas an open trough 7A for stenting purposes, may be used to maintain anopening of one or more of such natural outflows pathways. With thetrabecular stenting device 31 implanted as illustrated in FIG. 10,aqueous flows from the anterior chamber 20 through the device 31 intoSchlemm's canal 22, bypassing the trabecular meshwork 21, therebyreducing intraocular pressure within the eye 10.

A number of devices and methods for treating glaucoma and/or reducingintraocular pressure (IOP) may be utilized in conjunction with thepreferred embodiments. For example, a seton generally comprising atubular member or tube with opposed open ends may be used in trabecularmeshwork surgery to provide an outflow pathway for intraocular liquid tolower IOP. In cases, where temporary lowering of IOP is desired, forexample, during surgery other than that for glaucoma or chronic highIOP, an incision or opening may be created in the trabecular meshwork toprovide an outflow pathway for intraocular liquid to temporarily lowerIOP during surgery. This incision may then “fill in” over time torestore the trabecular meshwork to its normal state.

The following co-pending patent applications disclose devices andmethods for treating glaucoma and/or reducing intraocular pressure(IOP), among other things, the entire contents of each one of which arehereby incorporated by reference herein:

U.S. application Ser. No. 09/549,350, filed Apr. 14, 2000, entitledAPPARATUS AND METHOD FOR TREATING GLAUCOMA;

U.S. application Ser. No. 09/596,781, filed Jun. 19, 2000, entitledSTENTED TRABECULAR SHUNT AND METHODS THEREOF;

U.S. application Ser. No. 09/704,276, filed Nov. 1, 2000, entitledGLAUCOMA TREATMENT DEVICE;

U.S. application Ser. No. 09/847,523, filed May 2, 2001, entitledBIFURCATABLE TRABECULAR SHUNT FOR GLAUCOMA TREATMENT;

U.S. application Ser. No. 10/046,137, filed Nov. 8, 2001, entitled DRUGRELEASING TRABECULAR IMPLANT FOR GLAUCOMA TREATMENT;

U.S. application Ser. No. 10/101,548, filed Mar. 18, 2002, entitledAPPLICATOR AND METHODS FOR PLACING A TRABECULAR SHUNT FOR GLAUCOMATREATMENT;

U.S. application Ser. No. 10/118,578, filed Apr. 8, 2002, entitledGLAUCOMA STENT AND METHODS THEREOF FOR GLAUCOMA TREATMENT;

U.S. application Ser. No. 10/137,117, filed May 1, 2002, entitledGLAUCOMA DEVICE AND METHODS THEREOF; and

U.S. application Ser. No. 10/139,800, filed May 3, 2002, entitledMEDICAL DEVICE AND METHODS OF USE FOR GLAUCOMA TREATMENT.

Cataract Surgery

Referring in particular to FIG. 11, the transparency of the lens 26 ofthe eye 10 generally depends on the physiochemical state of the lensproteins. These proteins, like the proteins of other organs, aresensitive to changes in the properties of their surrounding fluid.Changes in the concentration of dissolved salts, in the osmoticpressure, in the pH or in the enzyme activity of the surrounding fluidcan alter the properties of the lens proteins. Also, like other organs,changes to the proteins of the lens occur with age. A common type ofcataract that occurs in elderly people is known as a senile cataract.This type of cataract has no known etiology and none of the forms ofcataract produced experimentally to date closely resemble the senilecataract.

Still referring to FIG. 11, the lens 26 of the human eye 10 is acrystalline lens that generally comprises an outer capsule 112 withanterior and posterior surfaces 114, 116, the lens 26 containing a clearcentral matrix 118. This central matrix 118 often opacifies with age andfor various other reasons (some of which have been mentioned above) andthereby progressively blocks the passage of light to the retina 18 ofthe eye 10. Eventually, the central matrix 118 attains a degree ofopacity which is referred to as a cataract. This abnormal ocularcondition is corrected by removing the lens, which is a procedure knownas cataract extraction, and replacing the lens by an artificial lens forfocusing the light entering the eye 10 on the retina 18. Intraocularlenses have gained widespread acceptance as replacements for cataractedhuman lenses.

Artificial intraocular lenses generally comprise an optical region and asupport, or haptic, to facilitate positioning and centering of theintraocular lens within the eye. Intraocular lenses have been made froma number of different materials. For example, hard lenses have beenprepared from polymethylmethacrylate (PMMA) and optical glass whileflexible lenses have been prepared from silicone, polyHEMA(polyhydroxyethylmethylmethacrylate), acrylics, collagen, andcombinations thereof. Flexible lenses have the advantage that they canbe folded or otherwise deformed prior to implantation to reduce theoverall size of the lens during the artificial lens implantationprocedure through an incision in the cornea or limbus. As discussedabove and further below, this small incision enables placement of aglaucoma stent passing the anterior chamber into a trabecular meshworkopening.

Artificial intraocular lenses are generally categorized as anteriorchamber intraocular lenses and posterior chamber intraocular lensesdepending on the implant locations. For example, Leiske in U.S. Pat. No.4,560,383, the entire contents of which are hereby incorporated byreference herein, discloses several embodiments of an anterior chamberintraocular lens that can be utilized in both primary and secondaryimplantations with either intracapsular or extracapsular cataractextractions. The lens is made of PMMA material that is low-mass,low-weight with reduced possibility of reaction and internal stress dueto eye movement or sudden movement.

FIGS. 12 and 13 show different views of one embodiment of an anteriorchamber intraocular lens device 120. The lens 120 generally comprises alens optic 122 and a pair of flexible opposing loops 124, 126 securedinto a side edge of the optic 122.

Further, for example, Faulkner in U.S. Pat. No. 4,366,582, the entirecontents of which are hereby incorporated by reference herein, disclosesseveral embodiments of a posterior chamber intraocular lens. Faulkner'slens is provided with a structure for engaging the anterior surface ofthe iris to retain the lens against posterior displacement within theeye, even if the capsule is missing or damaged.

FIGS. 14 and 15 show different views of one embodiment of a posteriorchamber intraocular lens device 130. The lens 130 generally comprises anoptic 132, support elements 134 and retaining elements 136.

Many other types of anterior chamber intraocular lens and posteriorchamber intraocular lens as known in the art and/or commerciallyavailable may efficaciously be utilized in conjunction with the surgicalprocedures taught or suggested herein. These lenses may be implanted inthe anterior chamber or posterior chamber of the eye, as needed ordesired.

During cataract surgery, typically the intraocular pressure is generallymaintained by injecting viscoelastic fluid or physiological saline at apre-specified pressure range (P_(N) in FIG. 16). However, the pressurefrequently undesirably spikes (as illustrated by line 140 in FIG. 16) toa high pressure or pressure range P_(H) after closing the incision inthe cornea (or limbus) because of “plugging” of the viscoelastic fluid.For a glaucoma patient, the combination of the pressure spike 140 andthe inherent high intraocular pressure, possibly due to intolerance ofglaucoma drugs post-operatively, complicates recovery of the cataractoperations.

It is one aspect of the invention to provide a method of treatingcataract of an eye while maintaining normal physiological intraocularpressure (P_(N) in FIG. 16). The method generally comprising combinationsteps of establishing an opening through trabecular meshwork, removingthe cataract, and inserting an intraocular lens, wherein the openingthrough trabecular meshwork comprises a trabecular stent having a lumentherein with optionally drug slow-releasing capability. The normalphysiological intraocular pressure P_(N) is preferably maintainedbetween about 10 mm Hg (mercury) and 21 mm Hg, during and after thecompletion of the surgical procedure.

The method may further comprise measuring and transmitting pressure ofthe anterior chamber of an eye, wherein the trabecular shunt comprises apressure sensor 40 for measuring and transmitting pressure. The meansfor measuring and transmitting pressure of an anterior chamber of an eyeto an external receiver 42 may be incorporated within a device that isplaced inside the anterior chamber for sensing and transmitting theintraocular pressure. Any suitable micro pressure sensor or pressuresensor chip known to those of skill in the art may be utilized.

One modern technique for removing the central opaque part of the lens orcataract is a procedure called phacoemulsification. Typically, the pupilis dilated to facilitate access to the cataract. In thephacoemulsification procedure, a sophisticated ultrasonic titaniumtipped instrument is introduced into the eye through an incision andpasses through the anterior chamber. This titanium tip is ultrasonicallyvibrated against the lens in a manner which emulsifies the opaquecentral matrix of the lens.

The emulsified matrix is then aspirated (using the same or differentinstrument) from the eye 10, and as best illustrated in FIG. 17, leavingthe original posterior capsule or surface 116 of the lens intact with asmall anterior capsular remnant or surface 114″. When the capsule 112 orpart of the capsule 112 is thus left inside the eye 10, the procedure iscalled extracapsular cataract extraction.

As illustrated by FIG. 17, extracapsular extraction allows theintraocular lens to be placed behind the iris 13 either in the spaceknown as a ciliary sulcus 150, that is the space immediately behind theiris 13 and in front of the anterior capsule remnant 114″ or in a spaceknown as the capsular bag 160, that is between a posterior surface 162of the anterior capsular flap 114″ and an anterior surface 164 of theposterior capsule 116.

Overall Surgical Procedure

FIG. 18 shows a schematic diagram illustrating steps of a combinedprocedure for cataract and glaucoma treatment which advantageouslycontrols or regulates the intraocular pressure (IOP) within apredetermined range. In some embodiments, the intraocular pressure iscontrolled during and after the surgical procedure. In otherembodiments, the intraocular pressure is controlled only during aportion of the surgical procedure and after the surgical procedure. Inyet other embodiments, the intraocular pressure is controlled only afterthe surgical procedure.

Preferably, an ab interno glaucoma procedure comprises one of thepre-cataract procedures. Optionally, an ab externo procedure may beutilized to lower IOP or treat glaucoma, as needed or desired.

In other embodiments, other pre-cataract procedures may includegoniotomy, trabeculotomy, trabeculopuncture, goniophotoablation, lasertrabecular ablation and goniocurretage. These embodiments and variationsthereof can have numerous disadvantages and sub-optimal success ratesbecause of undesirable tissue filling in.

As illustrated by FIG. 18, a stented ab interno glaucoma procedure (orlowering IOP procedure) may be conducted as a pre-cataract procedure inthe cataract/glaucoma combination procedure. In other embodiments, theglaucoma procedure (or lowering IOP procedure) may be performed afterthe cataract surgery or procedure. In yet other embodiments, theglaucoma procedure (or lowering IOP procedure) may be combined with(before or after) other types of eye surgeries or procedures, forexample, retinal surgery, vitrectomy, among others.

Referring in particular to FIG. 18, the accompanying ab interno glaucomaprocedure comprises a step 81 of creating an incision on a sclera orcornea wall; a step 82 of delivering or providing an applicator having atrabecular stent 82; a step 83 of creating an opening through trabecularmeshwork; and a step 84 of placing a trabecular stent over or throughthe opening while maintaining the intraocular pressure (IOP)peri-operatively. The opening in the trabecular meshwork may be made bya self-trephining stent, by the applicator itself or other cuttinginstrument as discussed above which is introduced through the incisionin the cornea or sclera.

Still referring to FIG. 18, the main cataract procedure comprises a step85 of extracting the diseased cataract lens; step 86 of maintaining theintraocular pressure peri-operatively within a specified range, step 87of implanting an intraocular lens while maintaining IOP; and step 88 ofsecuring the incision on the sclera or cornea wall while maintainingIOP. The step of extracting the cataract includes inserting aninstrument (as described above) through the incision in the cornea orsclera. Advantageously, the accompanying glaucoma procedure provides theeye with a balanced intraocular pressure post-operatively in step 89without the need of a IOP-lowering drug that may complicate the surgicalsuccess of the intended cataract procedure.

Advantageously, a single incision in the cornea or sclera may be used toperform both (or multiple) surgical procedures. Moreover, and desirably,the glaucoma and cataract may be treated in a single visit operationthat may be performed as an outpatient procedure with rapid visualrecovery and greatly decreased morbidity.

It should be noted that even patients without high IOP (or glaucoma) maydevelop temporary glaucoma or high IOP due to edema or swelling causedby the cataract procedure or other eye surgery. In such cases, the stentcan lower the IOP or a temporary opening may be created in thetrabecular meshwork which fills in over time but temporarily allowslowering of the IOP for a certain time period.

From the foregoing description, it will be appreciated that a novelapproach for the surgical treatment of glaucoma and cataract in onesingle operation (or one visit) has been disclosed for releasingexcessive or elevated intraocular pressure and correcting or treatingcataract. While the components, techniques and aspects of the inventionhave been described with a certain degree of particularity, it ismanifest that many changes may be made in the specific designs,constructions and methodology herein above described without departingfrom the spirit and scope of this disclosure.

Various modifications and applications of the invention may occur tothose who are skilled in the art, without departing from the true spiritor scope of the invention. It should be understood that the invention isnot limited to the embodiments set forth herein for purposes ofexemplification, but is to be defined only by a fair reading of theappended claims, including the full range of equivalency to which eachelement thereof is entitled.

1. (canceled)
 2. A method of performing an ocular medical procedure,comprising the steps of: creating an incision into an anterior chamberof a living human eye; removing lens tissue from the eye through theincision; introducing an artificial intraocular lens into the eyethrough the incision; introducing a flexible nitinol stent into the eyethrough the incision, the stent comprising a first portion comprising anelongate trough defining a channel that is open along a length of thefirst portion, and a second portion capable of fluid communication withthe first portion, the second portion having an opening to facilitateinflow of aqueous humor; and positioning the stent by advancing thefirst portion through a trabecular meshwork from within the anteriorchamber until the elongate trough is located within and extends along acircumferential length of Schlemm's canal with the open channel in anorientation that facilitates flow of aqueous humor toward one or morecollector channels in the eye and retaining the opening of the secondportion within the anterior chamber to facilitate flow of aqueous humorfrom the anterior chamber through the second portion into the openchannel of the elongate trough in Schlemm's canal.
 3. The method ofclaim 2, wherein the step of introducing the artificial intraocular lensis performed before the step of introducing the stent.
 4. The method ofclaim 2, wherein the step of introducing the stent is performed beforethe step of introducing the artificial intraocular lens.
 5. The methodof claim 2, wherein the method is performed without impacting a scleraor conjunctiva of the eye.
 6. The method of claim 2, wherein the stentincludes a protuberance to help stabilize the stent.
 7. The method ofclaim 2, wherein the stent is deployed from a cannula.
 8. The method ofclaim 7, wherein a sharpened end of the cannula is used to make anopening in the trabecular meshwork.
 9. The method of claim 8, whereinthe stent is at least partially inserted through the opening in thetrabecular meshwork.
 10. The method of claim 2, wherein the incisioninto the anterior chamber is self-sealing.
 11. The method of claim 2,wherein the incision into the anterior chamber is a corneal incision.12. A method of performing a medical procedure that combines a cataractoperation with a surgical implantation to treat glaucoma, comprising thesteps of: creating an incision into an anterior chamber of a livinghuman eye; removing lens tissue from the eye through the incision;introducing an artificial intraocular lens into the eye through theincision; introducing at least a portion of a cannula into the eyethrough the incision, wherein the cannula holds a flexible nitinol stenthaving a first portion defining a channel that is at least partiallyopen along a length of the first portion, and a second portion capableof fluid communication with the first portion, the second portion havingan opening to facilitate flow of aqueous humor into the second portion;using a sharpened end of the cannula to create an opening in atrabecular meshwork of the eye; advancing the stent through the openingin the trabecular meshwork; and positioning the stent so that the firstportion extends within and along a circumferential length of Schlemm'scanal, and the opening of the second portion is retained in the anteriorchamber, thereby allowing aqueous humor from the anterior chamber tobypass the trabecular meshwork through the stent.
 13. The method ofclaim 12, wherein the step of introducing the artificial intraocularlens is performed before the step of introducing at least the portion ofthe cannula.
 14. The method of claim 12, wherein the step of introducingat least the portion of the cannula is performed before the step ofintroducing the artificial intraocular lens.
 15. The method of claim 12,wherein the first portion of the flexible nitinol stent includes aplurality of openings along its length for the transmission of aqueoushumor.
 16. The method of claim 15, wherein the plurality of openingsconsists of three openings.
 17. The method of claim 12, wherein theincision into the anterior chamber is self-sealing.
 18. A method ofperforming a medical procedure that combines a cataract operation with asurgical implantation to treat glaucoma through a single incision,comprising the steps of: creating an incision into an anterior chamberof a living human eye; removing lens tissue from the eye through theincision; introducing an artificial intraocular lens into the eyethrough the incision; introducing at least a portion of a cannula intothe eye through the incision, wherein the cannula holds a biocompatiblemetal stent comprising titanium; creating an opening in a trabecularmeshwork of the eye using an ab interno approach; and positioning thestent through the opening so that it is located partially in theanterior chamber and partially within and along a circumferential lengthof Schlemm's canal, thereby allowing aqueous humor to bypass thetrabecular meshwork through the stent, wherein a first portion of thestent located within and along the circumferential length of Schlemm'scanal comprises an elongate trough defining a channel that is open alonga length of the first portion, and wherein a second portion of the stentlocated in the anterior chamber comprises an opening to facilitateinflow of aqueous humor.
 19. The method of claim 18, wherein thebiocompatible metal stent comprises nitinol.
 20. The method of claim 18,wherein the incision into the anterior chamber is self-sealing.
 21. Themethod of claim 18, further comprising an actuating step to release thestent from the cannula.
 22. The method of claim 18, wherein the step ofcreating an opening in the trabecular meshwork occurs as a result ofpositioning the stent.
 23. The method of claim 18, wherein thebiocompatible metal stent incorporates a slow-release pharmaceuticalsubstance.
 24. A method of performing a medical procedure that combinesa cataract operation with a surgical implantation to treat glaucoma,comprising the steps of: creating an incision into an anterior chamberof a living human eye through which the cataract operation is performed;introducing a delivery applicator into the eye through the incision,wherein the delivery applicator holds a flexible nitinol stentcomprising a first portion having an open, elongate shape and definingan open channel extending along an entire length of the first portion,and a second portion capable of fluid communication with the firstportion, wherein the second portion comprises an opening to facilitateinflow of aqueous humor into the second portion; using the deliveryapplicator to create an opening in a trabecular meshwork of the eye;advancing the stent through the opening in the trabecular meshwork;positioning the stent so that the first portion extends within and alonga circumferential length of Schlemm's canal and the opening of thesecond portion remains in the anterior chamber, thereby allowing aqueoushumor from the anterior chamber to bypass the trabecular meshworkthrough the stent.
 25. The method of claim 24, wherein the first portionof the stent includes a plurality of openings along its length for thetransmission of aqueous humor.
 26. The method of claim 24, wherein theincision into the anterior chamber is self-sealing.
 27. The method ofclaim 24, wherein the flexible nitinol stent releases a pharmaceuticalsubstance into the eye or ocular tissues.
 28. The method of claim 24,wherein the delivery applicator comprises a cannula.
 29. The method ofclaim 24, wherein the delivery applicator comprises a syringe.